Please note: This is the current version of the JDRF Terms and Conditions. The Terms and Conditions that your institution executed can be found within each individual award in the Research Officer (RO) portal in RMS360. Award Terms & Conditions JDRF AWARD NUMBER: X-XXX-XXXX-XXX-X-X JDRF AWARD TITLE: Title PRINCIPAL INVESTIGATOR: First Last GRANTEE INSTITUTION: University of JDRF The JDRF Terms and Conditions apply to all U.S. and international grantees. JDRF is committed to ensuring that all Board-mandated grants management and oversight requirements are met. To accomplish this goal, JDRF-funded organizations/institutions must comply with the grant terms and conditions outlined here. By accepting the grant, the Principal Investigator (“PI”) and the Grantee Institution agree to be legally bound to these Terms and Conditions. It is the responsibility of the Grantee Institution’s Financial Officials and Research Officers to ensure that all documentation submitted to JDRF conforms to the Terms and Conditions. JDRF allows the Grantee Institution and PI to manage their grant’s day-to-day activities following the Grantee Institution’s established policies, procedures, and practices so long as they are equivalent to (or more rigorous than) JDRF policy and requirements required under these Terms and Conditions. For questions regarding any administrative component of this document, please contact your JDRF Research Administrator: JDRF Administrator: First Last JDRF Contact Information: XXX-XXX-XXXX [email protected] JDRF Scientific Lead: First Last JDRF Contact Information: XXX-XXX-XXXX [email protected] JDRF RMS360 Effective February 2014, JDRF manages all awards through RMS360, a web-based grants management system designed to facilitate the Grantee Institution’s submission of materials from application through closeout. All documentation associated with an award’s lifecycle must be completed via JDRF’s RMS360. Information regarding RMS360 is available on the JDRF website. Under no circumstance does JDRF accept by email, fax, or mail any reports or documentation as required in the Terms and Conditions described here within. JDRF Terms and Conditions (Rev 01/17) 1 [pull from rms360 award number; PI last name] 1. Ethical Oversight 1.1 Human Subjects & Animal Welfare 1.1.1 Institutional Animal Care and Use Committees and Institutional Review Boards JDRF follows U.S. National Institutes of Health (NIH) Guidelines for the humane care and use of animals in research and for the use of human subjects in research and requires the Grantee Institution to comply with such Guidelines. According to U.S. Federal law, institutions that use laboratory animals for research or instructional purposes must establish an Institutional Animal Care and Use Committee (IACUC) to oversee and evaluate all aspects of the Grantee Institution’s animal care and use programs, facilities, and procedures. Institutions that utilize human subjects in research as defined by the Federal government must establish an Institutional Review Board (IRB) or Ethical Committee (EC). See NIH’s federal guidelines for more information. 1.1.2 JDRF Requirements The Grantee Institution must comply with all Federal, state and local government regulations regarding the participation of human subjects and the use of animals in research. No part of the Award may be used to support any research involving human subjects or animal studies that does not have the approval of the appropriate EC. All projects with human subjects and/or animal research must have up-to-date ethical approval documentation at all times For projects involving non-exempt human research, the Grantee Institution bears ultimate responsibility for protecting human subjects under the Award, including human subjects at all participating and consortium sites, and for ensuring that an Assurance approved by the Office for Human Research Protections (“OHRP”) and certification of IRB approval have been obtained before human subjects research can be conducted at each collaborating site. Where possible, JDRF strongly encourages the use of a Central IRB to improve the efficiency of conducting multi-site clinical studies. The Grantee Institution must ensure that JDRF receives required, up-to-date documentation for all sites in accordance with the Award milestone schedule and is current at the time of submission of award annual renewal materials. Failure to maintain and provide evidence of the necessary IRB and/or IACUC certification or the equivalent would constitute a material breach of these Terms and Conditions and give JDRF the right to enforce actions described in Section 6 including decision to terminate the Award. The JDRF Administrative Resources describe in detail the documentation required to satisfy the ethical approval requirement. Any changes to ethical documentation must be submitted to JDRF as approved. In the event that the IRB/EC has determined that the study is exempt, the documentation demonstrating the exempt status must be submitted to JDRF. The Grantee Institution must notify JDRF within 24 hours if there are any regulatory issues, protocol violations or policy changes that impact the ability of the research investigative team to conduct the research as part of this Award. Foreign Institutions: Ethical approval documentation submitted in a language other than English require a cover letter signed by the Grantee Institution’s department head (in English) verifying the content of the form and countersigned by the Grantee Institution’s Research Office of record. 1.1.3 Clinicaltrials.gov The Grantee Institution is required to register all non-exempt human subject studies in Clinicaltrials.gov database (including applicable clinical trials) to ensure information is freely available on JDRF funded trials within the T1D community. The registration should be no later than 21 days after the first subject is enrolled. 1.2 Confidentiality Most grant materials submitted to JDRF, including quarterly, milestone and annual progress reports, are for internal JDRF use only. Exceptions include the lay abstract and the annual web progress reports. As a public charity, JDRF has the responsibility to disclose details to the public regarding the organization’s funded portfolio. The lay abstracts and annual web progress reports will be disclosed to the public by JDRF upon award activation. The Grantee Institution and PI should not include any confidential or proprietary information, including intellectual JDRF Terms and Conditions (Rev 01/17) 2 [pull from rms360 award number; PI last name] property, in these materials and reports. In the event of a breach of confidentiality, the Grantee Institution and PI assume the responsibility for the premature disclosure. If you have any concerns or questions regarding inclusion of information in a particular report, please contact the applicable JDRF Grant Personnel. Except with respect to lay abstracts and annual web progress reports, JDRF shall treat as confidential all reports, invention disclosures, and other confidential information received from the Grantee Institution, and shall not disclose any such confidential information to any third party other than JDRF committee members or funding partners without the prior written consent of the Grantee Institution. Any such disclosure by JDRF shall be made subject to appropriate confidentiality restrictions. 1.3 Conflict of Interest In the interest of maintaining objectivity in research, JDRF must ensure that its grant processes are free from conflicts of interest. JDRF recognizes that the Grantee Institution may be involved in a variety of organizations and projects, and may hold financial investments, which may create actual or potential conflicts of interest, or the appearance of a conflict. The Grantee Institution is required to have established policies about, and safeguards against, conflicts of interest. The Grantee Institution must have protections in place that prevent the Grantee Institution and its employees or consultants/subcontractors from using their positions for personal gain (for themselves, or for other individuals, friends, business associates, family members, or others), financially or via gifts, favors, or other similar actions. The Grantee Institution is also responsible to ensure that all aspects of JDRF-funded research are not influenced by conflicts of interest, financial or otherwise. The Grantee Institution is required to have written guidelines to prevent such conflicts of interest, reflecting applicable institution/organization policy, along with state and local laws. A Grantee Institution that has identified conflicts of interest as they relate to JDRF-funded research should report these conflicts of interest, in writing, to its JDRF Research Administrator as soon as possible. 1.4 Scientific & Financial Misconduct The Grantee Institution is required to have its own policies and procedures for the avoidance and reporting of scientific and financial misconduct, and is required to enforce those guidelines (when applicable) to any JDRF-funded research. By accepting the JDRF award, the Grantee Institution acknowledges that it has such established policies and procedures and agrees to abide by them while conducting research or other activities relating to the JDRF award. In addition, JDRF follows the NIH’s research misconduct guidelines, which are defined as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results,” and the Grantee Institution agrees to comply